Chennai, Tamil NaduMadurai, Tamil Nadu

Job Summary

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Key Responsibilities

SCAR Implementation and Closure : Open SCARs (Supplier Corrective Action Request ) must be taken through formal closure

- Implement corrective actions and formally close all open SCARs with appropriate evidence.

Detailed review of open SCAR records to understand current status and gaps. Categorization of SCARs by supplier, product family, age, and severity.

Supplier follow-ups and coordination, Documentation completeness, Verification of implemented actions and Closure readiness aligned with FDA QSR expectations

Establish an inspection-ready supplier control framework through procedure gap assessment, ASL validation, and need-based supplier requalification.

Supplier follow-ups to obtain : Containment evidence. Root cause analysis documentation

Corrective action implementation details

Verification and documentation of implementation evidence

Support for effectiveness checks, as defined by client procedures

Preparation of complete SCAR closure documentation aligned to the client QMS and FDA QSR requirements

Supplier Controls and ASL Remediation

Gap assessment of the global purchasing & supplier management procedure against actual practices at the El Paso site

Documentation of identified gaps across process,



roles, records, and controls

Validation of approximately ASL suppliers, including : Classification as active or inactive

Mapping to products and supplier criticality

Execution of need-based supplier requalification, including : Updated supplier qualification forms

Risk assessment and supporting documentation review.

Support for supplier record migration readiness into Teamcenter (as per client-defined scope and rules).

Basic Qualifications : Proven ability to lead multiple SCAR Implementation and Supplier Controls projects.

Proficiency in the use of Microsoft Word, Excel, PowerPoint, Access, Microsoft Project.

Full time Degree in a relevant engineering field is required with 5 years of experience for Supplier Quality Engineer.

Solid written and verbal communications skills. Ability to write and independently manage the required technical documentation. Knowledge of the following standards : 21 CFR Part 820, ISO 13485, and ISO 14971.

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📌 Senior Developer - Mdr, 510(K), Dhf Remediation (Chennai)
🏢 HCLTech
📍 Chennai